MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3504310M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a breast surgery with a 550cc mentor tissue expander and experienced a deflation on an unknown side post-operatively.As a result, the patient underwent explantation on (b)(6) 2022.
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 22, 2022, mentor received additional information regarding the device serial number.The device serial number was updated to (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022, mentor received additional information regarding the device date of implantation and device date of explantation.The device date of implantation has been updated to (b)(6) 2022.The device date of explantation has been amended to (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 04, 2022, it was determined that the mentor failure analysis lab received the device for evaluation for this complaint on may 16, 2022.On july 08, 2022, the evaluation for the device was completed.Additional information states that the side of the implant was the right side.The patient's initials have been updated to s.N.In section a1 patient identifier.Device evaluation summary: visual analysis of the returned sample revealed that the exp rect remote 550cc breast implant was found to have a tear on the union between shell and patch.A microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue was addressed through mentor¿s quality system.During manufacturing, 100% of the devices were inspected for holes or tears.During the inspection, each device is inflated with air and submerged in 100% isopropyl alcohol (ipa).While submerged, a qualified operator will apply pressure on the device by gently squeezing and will observe for bubbles escaping the device that would indicate a leak.For the lot number reported in this complaint, no device was identified and rejected for leaks.In conclusion, with consideration to process controls and manufacturing records reviewed, the tear reported could not be confirmed as a manufacturing defect.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 14, 2022, mentor received additional information regarding the patient's date of birth and age.The patient's date of birth has been updated to (b)(6) 2016.The age of the patient has been updated to 6 years old.On july 27, 2022, mentor became aware that the the device evaluation summary in section h10 from the previous report erroneously referenced a breast implant when it should have been a tissue expander.The following device evaluation summary sentence has been updated from "visual analysis of the returned sample revealed that the exp rect remote 550cc breast implant was found to have a tear on the union between shell and patch." to "visual analysis of the returned sample revealed that the exp rect remote 550cc tissue expander was found to have a tear on the union between shell and patch." manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 6465917981
• MDR Report Key: 14059470
• Report Number: 1645337-2022-03966
• Device Sequence Number: 19988779
• Product Code: LCJ
• UDI-Device Identifier: 00081317002468
• UDI-Public: 00081317002468
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: 3504310M
• Device Catalogue Number: 3504310M
• Device Lot Number: 7711996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 04/22/2022; 05/02/2022; 07/04/2022; 07/14/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/11/2022; 05/26/2022; 07/08/2022; 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female